Engineering therapeutical extracellular vesicles for clinical translation

Area of Science:

• Biomedical Engineering
• Regenerative Medicine
• Nanotechnology

Background:

• Cell-based therapies show promise for disease reversal but face biosafety concerns.
• Cell-derived extracellular vesicles (EVs) mimic therapeutic benefits of cell transplants without inherent risks.
• Existing EV therapies encounter limitations in production scale, therapeutic payload, and targeted delivery.

Purpose of the Study:

• To review recent technological breakthroughs in extracellular vesicle (EV) bioengineering.
• To highlight advancements in enhancing therapeutic functionalities of EVs.
• To discuss the clinical prospects, biomanufacturing, regulation, and safety of bioengineered EV therapies.

Main Methods:

• Review of technological advancements in EV bioengineering over the past five years.
• Analysis of strategies to improve EV production, therapeutic loading, and targeting.
• Examination of biomanufacturing, regulatory, and safety considerations for clinical translation.

Main Results:

• Bioengineering has significantly improved EV production yields and therapeutic cargo loading.
• Novel targeting strategies enhance EV specificity and efficacy in preclinical models.
• Recent innovations address key challenges, paving the way for clinical adoption.

Conclusions:

• Bioengineered extracellular vesicles (EVs) represent a promising cell-free therapeutic modality.
• Technological advancements are crucial for overcoming current limitations and enabling clinical translation.
• Establishing robust biomanufacturing and regulatory frameworks is essential for the safe and effective adoption of EV therapies.